Bayer gets FDA approval for Adempas

By October 9, 2013 at 1:21 PM

The Food and Drug Administration has approved Adempas, a lung drug that treats two forms of pulmonary hypertension, marking a breakthrough for Bayer HealthCare, a German-based pharmaceutical with large operations in northern New Jersey.

The FDA reviewed Adempas under its priority review program, which provides an expedited six-month review for drugs that promise major advances in treatment.

Pulmonary hypertension is caused by abnormally high blood pressure in the arteries of the lungs, making the right side of the heart work harder than normal, according to the FDA. The condition can lead to death or require lung transplantation.

Adempas belongs to a class of drugs that help arteries relax to increase blood flow and decrease blood pressure.

The drug is intended for patients with chronic thromboembolic pulmonary hypertension, or CTEPH, after surgery or patients who cannot undergo surgery to improve their ability to exercise, the FDA said.

Adempas is also aimed at patients with pulmonary arterial hypertension to improve their ability to exercise and to delay clinical worsening of their condition.

Adempas is the first in its drug class approved to treat pulmonary hypertension and the first drug of any class to be shown to be effective for patients with CTEPH, said Dr. Norman Stockbridge, the director of the FDA’s Division of Cardiovascular and Renal Drug Products.

“This approval of Adempas equips physicians with a new approach to treating pulmonary hypertension patients,” Nick Kim, a clinical professor of medicine at the University of California San Diego, said in a statement.

Kim said surgery should always be considered as the first treatment option for CTEPH, but up to 40 percent of such patients are not eligible for surgery, and 10 to 35 percent of those patients have disease that persists after surgery.

Bayer HealthCare said the tablet drug will be shipped to distribution channels starting today. It has not disclosed sales projections for the Adempas.

Bayer HealthCare is in the process of centralizing area operations from four sites — in Wayne, Montville and Morristown, in New Jersey, plus a building Tarrytown, N.Y. — to one location in the Whippany section of Hanover.